Full procedure Import medicines for a pharmacy

Obtain a pharmacy licence for the premises

Licence of the Department of Medicines and Pharmacy, Ministry of Health, issued for one set of premises.

1. 1. Have the pharmacy inspected for fire safety
   Where: State Fire Inspectorate
   The inspector checks the materials room as a storage room. Shelving for alcohol-based solutions stands at least 1 m from any heater; a refrigerator counts as a heater if its grille faces the shelving.
   Bring: Lease or ownership certificate of the premises, Floor plan of the premises, 1:100, Application form (from the counter, filled in by hand in blue ink)
   You receive: Fire-safety inspection report on the storage room
   Cost: IS 180
   Time: 15–60 min in the queue, 40–90 min at the counter, 5–15 days until the next step
2. 2. Have the refrigerators' thermometers verified
   Where: Iradstandart, State Agency for Standards, Metrology and Certification
   Each refrigerator has two thermometers, one on the top shelf and one on the bottom shelf, and both are verified. The verification sticker is issued for the pair and the refrigerator together: a verified thermometer moved to another refrigerator is unverified.
   Bring: Lease or ownership certificate of the premises, Invoice of the foreign supplier
   You receive: Verification certificate of the thermometers of each refrigerator
   Cost: verification of each thermometer (two per refrigerator), IS 45 per refrigerator × 2
   Time: 30–90 min in the queue, 10–20 min at the counter, 5–10 days until the next step
3. 3. Pay the fee at Talasbank
   Where: Talasbank (any branch)
   Cost: licence fee, IS 1,800
   Time: 20–60 min in the queue, 5–10 min at the counter, 0–1 days until the next step
4. 4. Submit the application at room 214
   Where: Ministry of Health: Department of Medicines and Pharmacy
   The plan of the premises shows the sales hall, the materials room, the receiving area, the quarantine shelf for returned goods and the locked cupboard for medicines under special control, each with its area in square metres. Premises of less than 50 m² are licensed as a pharmacy kiosk, which may sell but may not import. The responsible pharmacist holds a diploma in pharmacy and works at no other pharmacy.
   Bring: Certificate of registration of the firm, Extract from the Register of Firms, Photocopy of the registration certificate, certified by the Register of Firms (6 copies), Lease or ownership certificate of the premises, Floor plan of the premises, 1:100, Fire-safety inspection report on the storage room, Verification certificate of the thermometers of each refrigerator, Notarised copy of the diploma of the responsible pharmacist, Application form (from the counter, filled in by hand in blue ink)
   Time: 60–180 min in the queue, 20–30 min at the counter, 20–30 days until the next step
5. 5. Receive the licensing commission at the pharmacy
   Where: Ministry of Health: Department of Medicines and Pharmacy (At the pharmacy)
   Who: Commission of three: a pharmacist of the Department, a fire inspector and a sanitary doctor
   The commission comes together or not at all. It compares the refrigerator temperatures with the morning entries in the temperature journal, which is kept from the day the application is submitted, including on days when the refrigerators are empty.
   Time: 0 min in the queue, 60–120 min at the counter, 10–20 days until the next step
6. 6. Collect the pharmacy licence
   Where: Ministry of Health: Department of Medicines and Pharmacy
   Valid for five years, for the premises named in it. A chain with three pharmacies holds three licences and imports for each pharmacy under its own licence.
   You receive: Pharmacy licence (for the premises named in it)
   Time: 30–90 min in the queue, 5–10 min at the counter, 0–1 days until the next step

Register each medicine with the Ministry of Health

State registration of each trade name, dosage form, strength and pack size, valid five years; Department of Medicines and Pharmacy.

7. 7. Submit the registration dossier for each medicine
   Where: Ministry of Health: Department of Medicines and Pharmacy
   One dossier per trade name, dosage form, strength and pack size: tablets of 250 mg in packs of 10 and in packs of 20 are two medicines. The dossier is filed in a ring binder of the Ministry's pattern, sold at the kiosk in the entrance hall of building 1, and the pages are numbered by hand.
   Bring: Pharmacy licence (for the premises named in it), Certificate of pharmaceutical product of the country of manufacture, with a notarised Iradi translation, Photocopy of the registration certificate, certified by the Register of Firms (6 copies), Application form (from the counter, filled in by hand in blue ink)
   Cost: registration fee, each medicine, IS 600 per medicine
   Time: 60–180 min in the queue, 30–60 min at the counter, 1–3 days until the next step
8. 8. Hand in samples at the State Laboratory
   Where: State Laboratory for the Quality Control of Medicines
   Six packs of each medicine: three for testing and three for the archive sample, which the laboratory keeps until five years after the registration expires. Samples of refrigerated medicines are received on Tuesdays only, in a cool box with a thermometer verified by Iradstandart.
   Bring: Certificate of pharmaceutical product of the country of manufacture, with a notarised Iradi translation
   You receive: Laboratory report on the quality of the medicine (one per medicine)
   Cost: quality testing, each medicine, IS 350 per medicine
   Time: 30–90 min in the queue, 15–30 min at the counter, 25–40 days until the next step
9. 9. Have the leaflet translated into Iradi and notarised
   Where: State Notary Office No. 1
   Bring: Label in all languages in which it is printed (3 copies of each)
   You receive: Notarised Iradi translation of the label
   Cost: translation of each leaflet, IS 90 per medicine
   Cost: IS 45
   Time: 40–150 min in the queue, 10–15 min at the counter, 3–7 days until the next step
10. 10. Register the leaflet text at window 2
    Where: Department of Public Information: registration of printed matter
    The leaflet is printed matter. The Iradi text may be on a separate sheet placed in each pack, but the sheet carries the Department of Public Information registration number of the leaflet it translates.
    Bring: Label in all languages in which it is printed (3 copies of each), Notarised Iradi translation of the label, Photocopy of the registration certificate, certified by the Register of Firms (6 copies)
    You receive: Registration number of the label text
    Cost: IS 150
    Cost: each leaflet, IS 40 per medicine
    Time: 30–120 min in the queue, 10–15 min at the counter, 20–35 days until the next step
11. 11. Collect the registration certificates
    Where: Ministry of Health: Department of Medicines and Pharmacy
    The Pharmacological Committee meets on the first Wednesday of each month and considers dossiers completed by the Friday before. The certificate gives the registration number, which is printed on, or stuck onto, every pack before sale.
    Bring: Laboratory report on the quality of the medicine (one per medicine), Registration number of the label text
    You receive: Registration certificate of the medicine (one per trade name, dosage form, strength and pack size)
    Time: 30–90 min in the queue, 5–10 min at the counter, 0–1 days until the next step

Register the contract and obtain approval to buy dollars

Registration at the Chamber of Commerce and Industry, deal passport at Talasbank, approval of the Currency Control Department of the Bank of Irad.

12. 12. Submit the contract for registration
    Where: Chamber of Commerce and Industry of Irad
    Form FTE-2, the registration card of a foreign trade participant, is attached to the first contract only. The contract lists each medicine by the name on its registration certificate.
    Bring: Foreign trade contract (original and two copies), Pharmacy licence (for the premises named in it), Photocopy of the registration certificate, certified by the Register of Firms (6 copies)
    You receive: Registration card of the foreign trade contract
    Cost: IS 250
    Time: 20–60 min in the queue, 20–30 min at the counter, 3–5 days until the next step
13. 13. Open a deal passport at Talasbank
    Where: Talasbank (any branch)
    Bring: Registration card of the foreign trade contract, Foreign trade contract (original and two copies), Photocopy of the registration certificate, certified by the Register of Firms (6 copies), ID card of the director of the firm
    You receive: Deal passport (opened at Talasbank)
    Cost: IS 150
    Time: 40–150 min in the queue, 20–40 min at the counter, 2–4 days until the next step
14. 14. Submit the request to the Currency Control Department
    Where: Currency Control Department, Bank of Irad
    Medicines are in the first category of the Department's priority list: the request is decided within ten working days instead of twenty-one, if every medicine in the contract is registered. A contract that lists one unregistered medicine is placed in the third category as a whole.
    Bring: Deal passport (opened at Talasbank), Registration card of the foreign trade contract, Invoice of the foreign supplier, Registration certificate of the medicine (one per trade name, dosage form, strength and pack size)
    You receive: Approval to purchase United States dollars for an import contract
    Cost: IS 300
    Time: 30–120 min in the queue, 15–20 min at the counter, 10–14 days until the next step

Obtain the permit to import the consignment

Permit of the Department of Medicines and Pharmacy for one consignment, listing each medicine by its registration number.

15. 15. Apply for the permit
    Where: Ministry of Health: Department of Medicines and Pharmacy
    The quantity of each medicine on the permit may not be exceeded by a single pack; a smaller quantity is accepted. Medicines kept between 2 and 8 °C are listed separately on the reverse, with their storage temperature.
    Bring: Pharmacy licence (for the premises named in it), Registration certificate of the medicine (one per trade name, dosage form, strength and pack size), Registration card of the foreign trade contract, Invoice of the foreign supplier, Approval to purchase United States dollars for an import contract, Application form (from the counter, filled in by hand in blue ink)
    Cost: IS 200
    Cost: each medicine listed, IS 15 per medicine
    Time: 60–180 min in the queue, 15–25 min at the counter, 1–2 days until the next step
16. 16. Receive the permit by registered post
    Where: Irad Pochtasy (registered mail)
    You receive: Permit to import medicines (one per consignment)
    Cost: IS 6
    Time: 10–40 min in the queue, 3–5 min at the counter, 7–14 days until the next step

Prepare the cold chain

Calibration of the lorry's thermograph by Hydromet; data loggers verified by Iradstandart where used.

17. 17. Have the lorry's thermograph calibrated
    Where: Irad Hydrometeorological Service (Hydromet), metrology section
    Refrigerated medicines travel between 2 and 8 °C. The Ministry's inspector accepts temperature records only from instruments calibrated by Hydromet. Thermographs fitted to lorries registered abroad are removed and brought to Talas.
    Bring: Technical passport of the vehicle, Registration card of the foreign trade contract
    You receive: Calibration certificate of the lorry's thermograph
    Cost: calibration, each lorry, IS 160 per lorry
    Time: 20–60 min in the queue, 15–30 min at the counter, 3–5 days until the next step
18. 18. Have the data loggers for the cold boxes verified ★ optional
    Where: Iradstandart, State Agency for Standards, Metrology and Certification
    A logger in each cold box is not required. Readings of loggers of a model not approved by Iradstandart are read at the terminal and not entered in the act.
    Bring: Invoice of the foreign supplier
    You receive: Verification certificate of the data loggers
    Cost: verification, each logger, IS 30 per logger
    Time: 30–90 min in the queue, 10–20 min at the counter, 3–5 days until the next step

Carry the consignment under customs seal from Chu Gate

Cargo policy of Iradstrakh and sealing by the licensed bonded carrier at the Chu Gate crossing.

19. 19. Buy the policy at the head office
    Where: Iradstrakh, State Insurance Company of Irad
    Bring: Permit to import medicines (one per consignment), Invoice of the foreign supplier, Photocopy of the registration certificate, certified by the Register of Firms (6 copies)
    You receive: Insurance policy for goods under customs bond
    Cost: premium, 0.15% of the invoice value, $0.0015 per US$
    Time: 20–60 min in the queue, 15–25 min at the counter, 0–1 days until the next step
20. 20. Hand the lorry to the bonded carrier for sealing
    Where: Trans-Chuy Freight & Logistics (licensed bonded carrier) (Chu Gate crossing, dispatch office of the carrier)
    A refrigerated lorry is not left on the Chu Gate parking overnight. If the seal cannot be applied before 17:00, the lorry waits on the Kazakh side with its refrigeration unit running.
    Bring: Permit to import medicines (one per consignment), Insurance policy for goods under customs bond, International consignment note (CMR), Calibration certificate of the lorry's thermograph
    You receive: Bonded transit document and customs seal
    Cost: carriage under seal, Chu Gate to Talas, each lorry, IS 420 per lorry
    Time: 30–240 min in the queue, 20–30 min at the counter, 1–2 days until the next step

Declare the medicines at the Talas Customs Clearance Terminal

Declaration at the Customs Service terminal and inspection of the consignment by the inspector of the Ministry of Health.

21. 21. Lodge the declaration
    Where: Customs Service: Talas Customs Clearance Terminal
    Registered medicines are free of import duty; the processing fee is charged. Each pack is counted against the permit by the importer's staff in the presence of the customs officer, in hall A.
    Bring: Bonded transit document and customs seal, Permit to import medicines (one per consignment), Registration certificate of the medicine (one per trade name, dosage form, strength and pack size), Registration card of the foreign trade contract, Invoice of the foreign supplier, Calibration certificate of the lorry's thermograph, Photocopy of the registration certificate, certified by the Register of Firms (6 copies)
    Cost: IS 150
    Cost: processing fee, 0.2% of the invoice value, $0.002 per US$
    Time: 60–300 min in the queue, 30–60 min at the counter, 0–1 days until the next step
22. 22. Have the consignment inspected by the Ministry's inspector
    Where: Ministry of Health: Department of Medicines and Pharmacy (Talas Customs Clearance Terminal, hall A)
    Hours: Tuesday and Friday, 10:00–13:00
    The inspector compares the registration number and the series on each pack with the permit and reads the thermograph. Refrigerated medicines are inspected first. Until the inspector's next day the lorry stands in the terminal yard with its refrigeration unit running, at the importer's cost.
    Bring: Permit to import medicines (one per consignment), Registration certificate of the medicine (one per trade name, dosage form, strength and pack size), Calibration certificate of the lorry's thermograph
    You receive: Act of inspection of the consignment by the Ministry of Health
    Time: 30–120 min in the queue, 60–180 min at the counter, 0–4 days until the next step
23. 23. Pay at the terminal's Talasbank desk and collect the release
    Where: Customs Service: Talas Customs Clearance Terminal
    Bring: Act of inspection of the consignment by the Ministry of Health
    You receive: Customs declaration with the release stamp
    Time: 30–120 min in the queue, 10–15 min at the counter, 0–1 days until the next step

Have each series tested at the State Laboratory

Testing of one pack of each series by the State Laboratory for the Quality Control of Medicines before sale.

Release each series for sale. Other option: Present the manufacturer's certificate for each series.

24. 24. Hand in one pack of each series
    Where: State Laboratory for the Quality Control of Medicines
    Until the certificate is issued the series stays on the quarantine shelf of the pharmacy, which is marked with a red label reading “Not for sale” in three languages.
    Bring: Customs declaration with the release stamp, Act of inspection of the consignment by the Ministry of Health
    Cost: testing, each series, IS 220 per series
    Time: 30–90 min in the queue, 15–30 min at the counter, 10–20 days until the next step
25. 25. Collect the certificates of release of each series
    Where: State Laboratory for the Quality Control of Medicines
    You receive: Certificate of release of the series for sale (one per series)
    Time: 20–60 min in the queue, 5–10 min at the counter, 0–1 days until the next step